Study on MB-CART2019.1 for Treating Relapsed or Hard-to-Treat Diffuse Large B Cell Lymphoma (DLBCL)

Sponsor: Miltenyi Biomedicine GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04792489

Provider View

This clinical trial is testing a new treatment called MB-CART2019.1 for patients with diffuse large B cell lymphoma (DLBCL) that has returned or not responded to at least two previous treatments. The study aims to evaluate the safety and effectiveness of this treatment.

Patient Parameters

Program Overview

The DALY II USA study is a phase II clinical trial conducted at multiple centers to test the effectiveness and safety of a new treatment called zamtocabtagene autoleucel (MB-CART2019.1) in patients with diffuse large B cell lymphoma (DLBCL) that has come back or not responded after at least two previous treatments. The study will also look at how the body processes the treatment.

Description

This study involves a new treatment using a patient's own T cells, which are modified to target specific proteins (CD19 and CD20) on cancer cells. Patients with relapsed or hard-to-treat DLBCL will have their T cells collected and modified in a lab. Before receiving the modified cells, patients will undergo a treatment to prepare their body, which may include medications like cyclophosphamide and fludarabine, or bendamustine. The modified cells will then be infused back into the patient through an IV. The study will start with a small group of patients to ensure safety, and then more patients will be enrolled. Participants will be monitored for up to two years to assess the treatment's effectiveness, safety, and impact on quality of life. Additional long-term follow-up will be conducted under a separate protocol.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with diffuse large B cell lymphoma (DLBCL) or a related subtype.
  • For CNS Cohort: B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL).
  • Cancer has returned or not responded after at least two lines of chemotherapy, including rituximab and anthracycline, and either failed a stem cell transplant or is not eligible for one.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 or 1, or 2 if due to DLBCL.
  • Measurable disease according to specific criteria.
  • Must provide a tumor biopsy sample from the most recent relapse.
  • No signs of central nervous system (CNS) lymphoma, unless part of the CNS cohort.
  • Adequate kidney, heart, and lung function.
  • Specific blood cell counts and liver function within normal limits.
  • Life expectancy of more than 3 months.

Exclusion Criteria

  • Primary CNS lymphoma, unless part of the CNS cohort.
  • DLBCL that developed from chronic lymphocytic leukemia (Richter's transformation).
  • Unable to give informed consent.
  • Active HIV or hepatitis B infection, or hepatitis C unless under control.
  • Uncontrolled seizures.
  • Recent stroke or autoimmune CNS disease.
  • Active systemic infection.
  • Pregnant or breastfeeding.
  • Other cancers within the last 5 years, except certain treated skin or prostate cancers.
  • Immunocompromised due to other conditions or treatments.
  • Recent heart problems or severe allergic reactions to study drugs.
  • Previous CAR-T therapy or certain other cancer treatments.
  • Refusal to participate in additional follow-up protocols.

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